Environmental Enrichment for Alcoholism

Overseen By Ryan E Tyler

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: National Institute on Drug Abuse (NIDA)

Must not be taking: AUD medications

Disqualifiers: Unstable conditions, Cybersickness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

44 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different activities and environments might affect drinking behaviors and mental health in individuals with alcohol use disorder (AUD). Participants will engage in activities such as virtual reality, games, puzzles, and crafts, or watch videos, to assess the impact on their alcohol craving and consumption. Known as Environmental Enrichment, this approach suits individuals diagnosed with AUD who consume more than 7 drinks per week for women or 14 drinks per week for men and are open to trying novel activities as part of their treatment. The study takes place in Baltimore and involves multiple visits to evaluate these effects. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to experience this innovative approach.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using FDA-approved medications for alcohol use disorder (AUD) or seeking treatment for AUD.

What prior data suggests that this protocol is safe for people with alcohol use disorder?

Earlier studies have shown that creating a stimulating environment can reduce relapse rates in people dealing with addiction. This approach, known as environmental enrichment, involves providing individuals with a variety of engaging activities. Research shows that this method is well-received and improves outcomes for those with substance use issues.

Animal studies suggested that a lively, engaging environment can help prevent addictive behaviors. These studies found no major safety concerns or negative effects, indicating that environmental enrichment is generally safe for humans.

Since this study is in its early stages, the main goal is to ensure the treatment's safety. This phase involves closely monitoring participants to confirm the approach is safe and well-tolerated. Prospective participants should know that this treatment aims to provide a non-medical way to improve mental health and reduce alcohol cravings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for alcohol use disorder that often involve medication or behavioral therapy, Environmental Enrichment focuses on altering the living environment to encourage healthier habits and reduce substance use. This innovative approach aims to stimulate the brain with engaging activities, social interactions, and sensory experiences, potentially leading to more sustainable recovery outcomes. Researchers are excited about this method because it addresses lifestyle factors and could complement existing therapies, offering a holistic way to support individuals in overcoming alcoholism.

What evidence suggests that environmental enrichment might be an effective treatment for alcohol use disorder?

Research has shown that creating a stimulating environment can be a promising way to treat alcohol use disorder (AUD). Studies have found that it might help reduce the desire to drink by offering enjoyable activities as alternatives. In animal studies, these enriched environments led to less drinking and fewer relapses. This trial will explore the effects of environmental enrichment on participants with alcohol use disorder. This method may work by changing how the brain reacts to alcohol triggers, making other activities more appealing. Early evidence suggests that activities like games, crafts, and virtual reality can help shift attention away from drinking. ^{6 7 8 9 10}

Who Is on the Research Team?

Lorenzo Leggio, M.D.

Principal Investigator

National Institute on Drug Abuse (NIDA)

Are You a Good Fit for This Trial?

This study is for adults over 21 with Alcohol Use Disorder (AUD). It's designed to see if different activities and environments can influence their drinking habits and mental health. Participants must be able to visit Baltimore up to 10 times.

Inclusion Criteria

I am at least 21 years old.

I own a smartphone and agree to use an app for study questionnaires.

Most recent Clinical Institute Withdrawal Assessment for Alcohol - revised (CIWA-Ar) score < 10

Exclusion Criteria

I am currently using or seeking treatment for alcohol use disorder.

Known history of clinically significant cybersickness

Medical and/or mental health conditions that are clinically unstable and would therefore compromise the safety and/or scientific integrity of the study, as determined by the MAI or study team respectively

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo a physical exam, blood and urine tests, a breath test for alcohol, and a body composition test. They answer questions about alcohol and substance use, mental and physical health, mood and anxiety, and sleep quality.

1 visit

1 visit (in-person)

Active Stage

Participants use a virtual reality system and engage in activities like video games, puzzles, books, and crafts. Sessions last for 3 hours.

1-3 months

Multiple visits (in-person)

Passive Stage

Participants watch videos selected by the research team. Sessions last for 3 hours.

1-3 months

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of alcohol consumption and cue reactivity.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Environmental Enrichment

Trial Overview

The trial tests the impact of Environmental Enrichment (EE) on alcohol consumption in AUD patients using a virtual reality system, various leisure activities, and video watching sessions. The study involves physical exams, questionnaires, an app for daily questions, and simulated bar environments.

How Is the Trial Designed?

Group I: Subject with alcohol use disorder Experimental Treatment 1 Intervention

subjects (Female/ Male) aged 21 and up

Who Is Running the Clinical Trial?

National Institute on Drug Abuse (NIDA)

Lead Sponsor

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

Exposure to environmental enrichment (EE) during abstinence from methamphetamine significantly reduced drug-seeking behavior in rats, suggesting a potential preventive strategy against relapse.

The reduction in drug-seeking was associated with decreased levels of glucocorticoid receptors (GR) in the hippocampus, indicating that EE may help restore the brain's stress response system disrupted by methamphetamine use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of relapse to methamphetamine self-administration by environmental enrichment: involvement of glucocorticoid receptors. Nicolas, C., Hofford, RS., Dugast, E., et al.[2022]

Male weanling rats raised in an enriched environment for 90 days consumed significantly more ethanol compared to those raised in isolation or those switched to isolation after enrichment.

Transitioning rats from an enriched environment to isolation led to a notable decrease in their voluntary ethanol intake, suggesting that continued exposure to an enriched environment is crucial for increased alcohol consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of environmental enrichment on voluntary ethanol intake in rats. Rockman, GE., Gibson, JE., Benarroch, A.[2019]

Environmental enrichment (EE) significantly enhanced the acquisition of schedule-induced drinking (SID) behavior in 24 male Wistar rats, with the EE group exhibiting faster development and higher drinking levels compared to the isolated group.

The results suggest that EE may promote SID through positive reinforcement rather than stress reduction, challenging previous assumptions about the relationship between environmental conditions and schedule-induced behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Environmental enrichment accelerates the acquisition of schedule-induced drinking in rats. Fuentes-Verdugo, E., López-Tolsa, GE., Pascual, R., et al.[2023]

Environmental enrichment during a 31-day abstinence period significantly reduced alcohol-seeking behavior in rats, suggesting a potential strategy to prevent relapse after periods of abstinence.

The study involved training rats to self-administer alcohol and then punishing their behavior in a different context, highlighting the effectiveness of enriched environments in mitigating cravings for alcohol.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Environmental enrichment reduces the propensity to relapse following punishment-imposed abstinence of alcohol seeking. Campbell, EJ., Jin, S., Lawrence, AJ.[2020]

A randomized controlled trial involving 135 participants with severe alcohol use disorder (AUD) will assess the effectiveness of a new environmental enrichment (EE) protocol, which includes mindfulness in virtual reality and physical activity, in reducing relapse rates after treatment.

The study aims to show that participants receiving the EE intervention will have a lower relapse rate at 2 weeks post-treatment compared to a control group receiving standard AUD management, with additional assessments of craving and mindfulness skills over 1 and 3 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of environmental enrichment on relapse rates in patients with severe alcohol use disorder: protocol for a randomised controlled trial. Barillot, L., Chauvet, C., Besnier, M., et al.[2023]

Environmental enrichment (EE) shows promise as a therapeutic strategy for treating substance use disorders, as it has been shown to reduce compulsive drug-taking and prevent relapse in animal models.

Clinical evidence suggests that multidimensional EE interventions, which include physical activity and social interaction, may have similar beneficial effects on reducing cravings and promoting long-term recovery in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic efficacy of environmental enrichment for substance use disorders. Galaj, E., Barrera, ED., Ranaldi, R.[2021]

Environmental enrichment increased ethanol intake specifically in female rats, suggesting that enhanced exploration of new environments may lead to higher alcohol consumption in this group.

The study indicates that while environmental enrichment can promote exploratory behavior, it may also inadvertently increase the risk of ethanol intake, particularly in females, highlighting the need for caution in clinical programs aimed at treating alcohol use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Environmental enrichment during adolescence heightens ethanol intake in female, but not male, adolescent rats that are selectively bred for high and low ethanol intake during adolescence. Suárez, A., Fabio, MC., Bellia, F., et al.[2021]

Citations

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Exposure of Sardinian alcohol-preferring (sP) rats to an enriched environment (EE) reduced different aspects of operant alcohol self-administration.

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Ethanol significantly reduced BDNF levels in adolescents reared under standard housing conditions, but not in adult mice nor in adolescents ...

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Preclinical studies have shown that exposure to a multisensory, stimulating environment (environmental enrichment, EE) can prevent the development of addictive ...

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Key findings from this updated review indicate that enrichment produces positive outcomes in drug abuse vulnerability beyond just psychostimulants.

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Environmental Enrichment During Adolescence Mitigates ...

This study investigated long-term consequences of continuous and intermittent maternal alcohol drinking on behavioral readouts of cognitive function and ...